FDA Inspection
Purdy-Pak, Inc. dba Tite-Pak & PPIPurdy-Pak, Inc. dba Tite-Pak & PPI – FDA Inspection, Sep 11, 2013
Record Details
This FDA Inspection record concerns Purdy-Pak, Inc. dba Tite-Pak & PPI, with an inspection on September 11, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Inspection Date
- September 11, 2013
- Product Type
- Veterinary
View Company Profile
ID · 6e7daa04-4c9e-4dff-a7b4-cc8257829ce6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 845833
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
13- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.67(b)Written procedures fail to include
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.